JERUSALEM--(BUSINESS WIRE)--Jul. 1, 2013--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that
data from the Glatiramer Acetate
Low-frequency Administration
(GALA) study, published in the Annals of Neurology, show that a
40mg/ 1mL dose of COPAXONE® (glatiramer acetate injection)
administered subcutaneously three times per week significantly reduced
relapse rates at 12 months and demonstrated a favorable safety and
tolerability profile in patients with relapsing-remitting multiple
sclerosis (RRMS). Currently, the approved dose for COPAXONE®
is 20mg/ 1mL, which is a once a day subcutaneous injection.
The GALA study, a multinational, phase III, double blind, placebo
controlled study, was designed to evaluate the efficacy, safety and
tolerability of an investigational 40mg/ 1mL dose of GA given three
times a week over a period of 12 months for the treatment of RRMS.
The published data show that glatiramer acetate (GA) 40mg/ 1 mL
injections administered three times a week reduced annualized relapse
rates by 34.0% (p<0.0001), reduced the cumulative number of new and
enlarging T2 lesions by 34.7% (p<0.0001) when measured at six and 12
months, and the cumulative number of gadolinium enhancing lesions by
44.8% (p<0.0001) when measured at six and 12 months, as compared to
placebo in patients with RRMS.
“We are pleased with the positive data of the GALA study which may lead
to meaningful benefits for RRMS patients,” said lead study author Omar
Khan, M.D., Professor of Neurology and Chair of the Department of
Neurology, Wayne State University School of Medicine, Detroit, MI.
“COPAXONE® 40mg/ 1 mL given three times a week demonstrated a
favorable safety and tolerability profile, with the overall frequency of
adverse events comparable to those seen in the placebo group.”
The most common adverse event in the GA group was injection site
reactions (35.5% with GA vs. 5.0% with placebo).
About the Study
The objective of the GALA study was to assess the efficacy and safety of
glatiramer acetate (GA) 40mg/ 1mL administered three times weekly (tiw)
compared with placebo in patients with relapsing–remitting multiple
sclerosis (RRMS).
This randomized, double-blind study was conducted in 142 sites in 17
countries. Patients with RRMS with at least one documented relapse in
the 12 months before screening, or at least two documented relapses in
the 24 months before screening, and an Expanded Disability Status Scale
score ≤ 5.5, were randomized 2:1 to receive either subcutaneous (sc) GA
40mg/ 1mL tiw or placebo for 12 months.
Of 1,524 patients screened, 1,404 were randomized to receive GA 40mg/
1mL sc tiw (n = 943) or placebo (n = 461). Ninety-three percent and 91%
of patients in the placebo and GA groups, respectively, completed the
12-month study. GA 40mg/ 1mL tiw was associated with a 34.0% reduction
in risk of confirmed relapses compared with placebo (mean annualized
relapse rate = 0.331 vs 0.505; p < 0.0001). Patients who received GA
40mg/ 1mL tiw experienced highly significant reduction (p < 0.0001) in
the cumulative number of gadolinium-enhancing T1 (44.8%) and new or
newly enlarging T2 lesions (34.7%) at months 6 and 12. GA 40mg/ 1mL tiw
was safe and well tolerated. The most common adverse events in the GA
group were injection site reactions (35.5% with GA vs 5.0% with placebo).
About COPAXONE®
COPAXONE® (glatiramer acetate injection) is indicated for the
reduction of the frequency of relapses in relapsing-remitting multiple
sclerosis, including patients who have experienced a first clinical
episode and have MRI features consistent with multiple sclerosis. The
most common side effects of COPAXONE® are redness, pain,
swelling, itching, or a lump at the site of injection, flushing, rash,
shortness of breath, and chest pain. See additional important
information at http://copaxone.com/pdfs/PrescribingInformation.aspx.
For hardcopy releases, please see enclosed full prescribing information.
COPAXONE® is now approved in more than 50 countries
worldwide, including the United States, Russia, Canada, Mexico,
Australia, Israel, and all European countries.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
leading generic drug maker, with a global product portfolio of more than
1,000 molecules and a direct presence in about 60 countries. Teva's
branded businesses focus on CNS, oncology, pain, respiratory and women's
health therapeutic areas as well as biologics. Teva currently employs
approximately 46,000 people around the world and reached $20.3 billion
in net revenues in 2012.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the
current beliefs and expectations of management. Such statements are
based on management’s current beliefs and expectations and involve a
number of known and unknown risks and uncertainties that could cause our
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products,
competition for our innovative products, especially Copaxone® (including
competition from innovative orally-administered alternatives, as well as
from potential purported generic equivalents), competition for our
generic products (including from other pharmaceutical companies and as a
result of increased governmental pricing pressures), competition for our
specialty pharmaceutical businesses, our ability to achieve expected
results through our innovative R&D efforts, the effectiveness of our
patents and other protections for innovative products, decreasing
opportunities to obtain U.S. market exclusivity for significant new
generic products, our ability to identify, consummate and successfully
integrate acquisitions, the effects of increased leverage as a result of
recent acquisitions, the extent to which any manufacturing or quality
control problems damage our reputation for high quality production and
require costly remediation, our potential exposure to product liability
claims to the extent not covered by insurance, increased government
scrutiny in both the U.S. and Europe of our agreements with brand
companies, potential liability for sales of generic products prior to a
final resolution of outstanding patent litigation, our exposure to
currency fluctuations and restrictions as well as credit risks, the
effects of reforms in healthcare regulation and pharmaceutical pricing
and reimbursement, any failures to comply with complex Medicare and
Medicaid reporting and payment obligations, governmental investigations
into sales and marketing practices (particularly for our specialty
pharmaceutical products), uncertainties surrounding the legislative and
regulatory pathways for the registration and approval of
biotechnology-based products, adverse effects of political or economical
instability, corruption, major hostilities or acts of terrorism on our
significant worldwide operations, interruptions in our supply chain or
problems with our information technology systems that adversely affect
our complex manufacturing processes, any failure to retain key personnel
or to attract additional executive and managerial talent, the impact of
continuing consolidation of our distributors and customers, variations
in patent laws that may adversely affect our ability to manufacture our
products in the most efficient manner, potentially significant
impairments of intangible assets and goodwill, potential increases in
tax liabilities, the termination or expiration of governmental programs
or tax benefits, environmental risks and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2012 and in our other filings with the U.S. Securities and Exchange
Commission. Forward-looking statements speak only as of the date on
which they are made and the Company undertakes no obligation to update
or revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix,
215-591-8912
United States
or
Ran Meir,
215-591-3033
United States
or
Tomer Amitai, 972
(3) 926-7656
Israel
or
PR:
Iris Beck Codner,
972 (3) 926-7687
Israel
or
Denise Bradley,
215-591-8974
United States